IM Regulatory Validation Lead

TechDigital Group; Raritan (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva and AWS cloud technology. The ideal candidate will have over 8 years of experience in Computer System Validation or Quality Management, with a strong understanding of regulatory compliance. Responsibilities include authoring validation deliverables, developing validation strategies, and providing guidance on SDLC processes. This role requires excellent communication and the ability to lead cross-functional teams.

Qualifications

• 8+ years of experience in Computer System Validation, Quality Management, or Business Analysis in GxP.
• Ability to author validation deliverables such as Validation Plans and Reports.
• Experience in supporting audit processes and Application Lifecycle Management.

Responsibilities

• Lead end-to-end validation ownership for a Unified Regulatory Platform.
• Develop validation strategies for projects.
• Prepare change control documentation and coordinate go-live activities.

Skills

Computer System Validation

Quality Management

Business Analysis

Project Planning

Analytical Thinking

Problem Solving

Tools

JIRA

qTest

SNOW

Job description

Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack

• 8+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area Act as single point of accountability for validation deliverables,
• Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.,
• Developing validation strategy for projects
• Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed
• Providing audit support and support Application Lifecycle Management
• Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations
• Ability to guide cross-functional teams
• Broad experience in Computer System Validation (CSV) and testing
• Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11
• Clear written and verbal communication, especially for technical documentation
• Solid understanding of the fundamentals of iterative and incremental software development
• Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
• Skilled in project planning, execution and minimal rework strategies
• Capable of risk identification and mitigation, especially in regulated environments
• Strong Analytical and Problem solving